This Is MS Multiple Sclerosis Community: Knowledge & Support

Welcome to the world's leading forum on Multiple Sclerosis research, support, and knowledge. For over 10 years, This is MS has provided an unbiased community dedicated to Multiple Sclerosis patients, caregivers, and affected loved ones.

My point is: why can't case reports on treatments in MS patients get published like this?

After reading this you can draw your own conclusions.

A few years ago the makers of Prokarin conducted a double-blind, placebo controlled clinical trial of Prokarin for its effect on fatigue. The study got published in The MS Journal, a rather prestigious MS publication which operates out of the University of Pennsylvania. The editor stated that the trial was good science, the results were encouraging and that more trials were warranted.

Good Morning America (daily tv news program) was ready to do a feature story on the trial and had contacted EDMS, the company that developed Prokarin and who funded the trial. GMA also contacted the NMSS for their point of view. Within hours, Good Morning America canceled the story and the NMSS wrote a less than flattering press release about the trial. The NMSS didn't even have the published trial in their hands when they wrote the release since The MS Journal had not released it to the public as yet. The NMSS has since re-written their comment on the trial but the damage had already been done.

Prokarin's theory of how it works goes against the current auto-immune belief of MS and we all know how much monetary support the CRAB drug makers give to the NMSS.

Advertisement

I agree, there seems to be a strong publication bias when it comes to MS research. Although I read plenty of PubMed abstracts of review articles that state the current treatment options for MS are extremely suboptimal, and there is a continued clamor for better treatments. There is one thing everyone seems to agree on, the accepted, approved drugs are not very good. I could post numerous PubMed abstracts that make this statement regarding treatment, but I won't bore everyone.

Given that consensus about existing treatments, to publication forums for case reports and case series investigating either 1) treatment, or 2) characteristics in MS patients that might point to etiology, are seriously lacking. Given the state of treatment and the state of knowledge regarding what causes MS, I don't consider publications on either topic a waste of ink. That raises the ugly possibility of information suppression, as your email suggested. I found the abstract for what appears to be the Prokarin trial, it was a 2002 trial of short duration, and looked at endpoints on fatigue and performance on tests. The first author is Gillson. Is this the trial you were talking about? I don't know what NMSS's criticisms were and how that could have squelched research into Prokarin.

I don't know if research publications on other diseases shows the same constraints, since I haven't looked into any of them like I have MS. Lupus and some forms of arthritis may have some of the same characteristics as the state of the science as MS, I don't know. My impression is that cancer research is much more open to publishing alternative treatment possibilities, but that may be due to the nature of cancer, and that treatment centers may be more willing to try treatments on cancer patients, and they can get data on whether or not the treatment worked more quickly in cancer patients.

I am concerned, though, that the publication playing field is not level at all. There is this big push and emphasis on evidence-based medicine (EBM). And to play at the EBM table, publication and peer review is the first step for consideration.

I found the abstract for what appears to be the Prokarin trial, it was a 2002 trial of short duration, and looked at endpoints on fatigue and performance on tests. The first author is Gillson. Is this the trial you were talking about? I don't know what NMSS's criticisms were and how that could have squelched research into Prokarin.

Yes, there was only one small clinical trial done on Prokarin and Dr. Gillson was the medical doctor in charge of it at that time.

I'll try to make this story as short as possible. This clinical trial was done mostly because the NMSS demanded from Elaine Delack (inventor of Prokarin) that a scientific study be done before they would consider Prokarin for possible use in the treatment of MS related fatigue.

Prior to this trial, the NMSS was extremely upset with Elaine because a tv station in Seattle WA had done a story on some of the early success of Prokarin during some pilot studies. It was the station that pushed for the story and interview and not Elaine. She was very reluctant for many reasons.

Elaine paid for the trial out of her own pocket in the hope that the NMSS would give Prokarin the same kind of consideration it gave other off label drugs as long as the results were positive. In the meantime the NMSS was less than cordial to Elaine or Prokarin and they made some very false statements about the drug.

The trial was completed and published by The MS Journal. It isn't a very easy task for a non-pharma company or unknown researcher to get a trial published by a well-known MS journal. The editor stated the trial was good science, properly conducted and showed good enough results to merit further trials.

The day The MS Journal released their publication, the NMSS called Elaine and asked for a copy of the trial.( at 1600 Eastern Time) They wanted to issue a press release on the trial. She didn't have it since the final published trial data is totally controlled by the publisher (in this case the MS Journal) Elaine told the NMSS she could get them one but it would take a couple of days.

In the meantime, Good Morning America (tv news show) had contacted Elaine's publicist at the time (again, same date as the NMSS did but earlier in the day) and wanted a copy of the trial in order to do a news item on their daily show. The final trial publication wasn't available (reason above) but the publicist told ABC that she could fax them an earlier incomplete draft of the trial but that it would have to be for their own in-house info only and could not be used for quotation purposes. It was simply done as a courtesy so ABC had some idea of what took place in the trial.

Within an hour of that 1600 call, the NMSS issued a press release about the trial (without even having the trial in hand or reading it) and made some very inaccurate comments. (the information as posted on their website was changed later on) ABC News called the publicist and informed her the news story was cancelled....without giving a reason. When the NMSS was challenged on their press release, they told Elaine that her publicist faxed them the trial data when in fact it was ABC News who faxed them the early draft copy that they had received. The NMSS had lied about the fax origination and when they sent a copy of it to Elaine as "proof" it came directly from her publicist, they forgot to realize that the ABC News "sender" fax number was printed at the very top of the page! The NMSS also stated that they had never phoned Elaine for a copy of the final trial data!

Elaine set up a meeting with the NMSS in New York because they now wanted her to explain the trial data and theory behind Prokarin. The meeting was a farce because the people who attended couldn't understand any of the scientific info that she was trying to explain to them and they made it clear they had no intention of considering Prokarin as a possible alternative medication for MS fatigue.

There are other details that I have left off in this story, especially the behavior of some of the NMSS upper executive, but it gives you an idea of how the NMSS picks and chooses what they want known about what is going on in MS. Prokarin was perceived as a threat to the established world of MS medicine at that time and in no way was the NMSS going to acknowledge it as a possible fatigue treatment. It was at this point that Elaine decided it would be fruitless to conduct further expensive trials that would cost millions which she simply didn't have.

You start to wonder just what other possibilities for MS treatment have never got to the public stage.

You start to wonder just what other possibilities for MS treatment have never got to the public stage.

Is it because I'm from the UK that I don't understand this anti-NMSS stuff?

Last year I received correspondence from the head of the NMMS and its head of research. I found their response to the issues I raised to be extremely thoughtful and honest, and they both appeared driven to end this disease. At the end iof the day the NMSS is one of the major funders of MS research. Their Promise 2010 initiative offers real hope for the future - to stop the disease and to repair damage done.

Yet like a broken record the same issues crop up - LDN and Prokarin and allegations of cover-ups etc etc. We have 2500 ish users of this site. How many are on LDN? How many have seen real / verified improvements? I'm not hearing that many success stories? In reality, if someone was seeing great benefits they would tell their MS friends who would try it and they would see benefits etc etc. The fact that this isn't the case, suggests to me that it isn't having great results. I would suggest the same could apply to Prokarin. Dr B who is promoting LDN claims that only one of his patients has had a relapse - I don't believe it.

I met Dr Coles last week (he who wrote the article about LDN for the UK MS Society). I think it is an insult to people such as him to suggest that he would reject a therapy because it didn't fit with his view on the disease.

Conspiracy theories are fine, but at the end of the day don't do anything to help those with this disease. An on the grounds of natural justice, some big allegations are being made, without anyone having an opportunity to defend themselves.

Is it because I'm from the UK that I don't understand this anti-NMSS stuff?

The "anti-NMSS" comments you read here pretty much refer to US office. From what I have read for the past several years, the Canadian and UK offices, which are much smaller, operate quite differently.

I have corresponded and spoken to some former NMSS employees in the US and they have had some less than flattering comments to make about that organization. Elaine Delack got to experience how these people operate first hand when she met with them on two occasions. Montel Williams (US TV personality who has MS) was so disgusted on how the NMSS operated that he started his own foundation for MS research funding.

Yet like a broken record the same issues crop up - LDN and Prokarin and allegations of cover-ups etc etc. We have 2500 ish users of this site. How many are on LDN? How many have seen real / verified improvements? I'm not hearing that many success stories? In reality, if someone was seeing great benefits they would tell their MS friends who would try it and they would see benefits etc etc. The fact that this isn't the case, suggests to me that it isn't having great results. I would suggest the same could apply to Prokarin. Dr B who is promoting LDN claims that only one of his patients has had a relapse - I don't believe it.

You are obviously not reading the sites that follow LDN and discuss its benefits. The group that is trying to promote a clinical trial is centred in the UK! Dr. Bob Lawrence, the UK doc who has MS himself, has so many UK patients using LDN, he can't take on any more patients. There are thousands of patients around the world using LDN successfully but we all know very well that the evidence is anecdotal and can't be used for scientific purposes.

The big question is why nobody has come forward to spend the money to do a clinical trial. The answer, Ian, is obvious....the drug is beyond patent and no drug company in their right mind would touch it. So why doesn't the NMSS fund an initial trial? Because if the drug proved to be at least as good as the CRABs, goodbye CRABs and goodbye all the funding they give to the NMSS. Why else, then, hasn't anyone taken an extremely inexpensive drug taken in pill form and done trials? It doesn't make sense. Instead the NMSS pays Dr. Alan Bowling to write a terribly inaccurate press release on LDN which he later has to change because it was so badly written.

And this is one reason why the US NMSS organization is not very highly thought of by many people on this side of the Pond.

Conspiracy theories are fine, but at the end of the day don't do anything to help those with this disease. An on the grounds of natural justice, some big allegations are being made, without anyone having an opportunity to defend themselves.

The UK LDN group communicated with the UK NMSS a few years ago. I won't go into detail but the reception they got wasn't very pleasant. If you like, I can put you in touch with the group leader in your neck of the woods and you can obtain all the details from her.

I'm not intending to fan a conspiracy theory against anyone or organization in particular. I'm genuinely puzzled about the LDN issue and lack of any published studies relating to MS and didn't know the history on the response to the Prokarin publication. I agree with Bromley there should be some published data to look at, and that's what I'm asking for. I disagree with Bromley that no one is having a good response to LDN, or they would be telling their friends, etc. That is how the use of LDN has expanded, it is largely through word of mouth, and the internet. It appears all from grassroots. There is no one organization, no manufacturer that promotes it, promotion is the users themselves. It doesn't seem to help everybody who tries it, but then no MS drug does that. If 100% response in everybody was the measure of effectiveness, then none of the MS drugs out there are any good. The fact that it could help at least some of the people taking it is worthy of study.

So back to the publication question - Naltrexone is being used in pilot treatments for a variety of conditions, from the pancreatic cancer in this thread to hyperinsulinema - that I posted on another thread. There are more people taking LDN for MS than for either pancreatic cancer or hyperinsulinemia - of that I'm pretty certain. Yet no doctor who has prescribed LDN in MS patients has published a single case report or case series, to my knowledge. Why is that? What makes MS research so exclusionary? Other researchers or clinicians working on some other disease seem to have no trouble publishing their case reports and small scale clinical tests with naltrexone. It raises the question of whether there is no data for naltrexone in MS (positive or negative, and I doubt it given the number of people taking it there's no data) or whether there is some other impediment to publishing results. Whether the impediments, if they exist, are scientific bias, business interests, or legal, I don't know. Harry raised the possible business interest ones in the last post. Who knows?

Yet no doctor who has prescribed LDN in MS patients has published a single case report or case series, to my knowledge. Why is that? What makes MS research so exclusionary?

A more than interesting question, isn't it!?

Over the years that I have followed MS, I have noticed that the research field and related areas of publication in this area have been the exclusive domain of the MS docs and the pharmas who deal with the disease. The family doc doesn't dare venture into this area even if he is treating his MS patient successfully with some other medication.

An example....when my wife and I first moved to London ON from Toronto, we tried to get our new family doc to prescribe Prokarin. No way he said....he was totally afraid of what the MS neuros at the clinic here would think of him if they ever found out. It didn't matter that my wife had been using Prokarin successfully for 2 years at that time. We were then able to convince Marg's neuro to rx the Prokarin. Now two months ago, as the clinic is trying to farm out their prescription work to the family docs, the neuro wrote a note to our family doc that he could prescribe the Prokarin for Marg!! Our doc received the blessing from the neuro and now it was OK!

Of course this doesn't happen all the time but I believe that the treatment of MS, due to its total unpredictability and variance in patients, is a very closed area of medicine. When anyone in medicine comes along with a new theory, it doesn't appear to get very far or at times, even acknowledged. Look at the work that Drs. Prineas and Barrett did when they autopsied the young lady who died suddenly from a massive exacerbation. They published a report stating that they found no evidence of immune system activity in the fatal brain lesion of that MS patient. That goes against most of the current thinking of MS docs and so far, you hear very little about the report.

So it doesn't surprise me that nobody has written much about any success they have had using LDN on their patient. The subsequent ridicule they may be subject to isn't worth it to them.

bromley wrote:In reality, if someone was seeing great benefits they would tell their MS friends who would try it and they would see benefits etc etc. The fact that this isn't the case, suggests to me that it isn't having great results.

"Trying it" is easier said than done. I managed to get an LDN prescription from my last PCP (after hearing success stories from my MS friends) until the doctor became affiliated with a major hospital system. At my last visit with her, she claimed that she was no longer allowed to prescribe meds off label and that she "could be arrested" for giving me LDN. Then she sent me a certified letter firing me as a patient.

My previous PCP refused to prescribe LDN at all because, "Drug addicts will attack you in order to take it away from you." (Huh?)

The PCP I had before that one was basically freaked when he found I had MS and ran out of the examining room to call my neuro to tell her about my LDN request. She subsequently fired me for refusing CRAB meds.

My current neuro (at a major MS Clinic) says she's "supposed to" prescribe a CRAB med to me and that she "can't" prescribe LDN.

Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)

You have described the classic situation for current MS medicine and MS docs! It's amazing that they hold some of the thoughts that you mentioned....."the drug addicts will attack you for the LDN".... how someone with the education that doc would have received over the years could possibly come up with such a comment is mind boggling!

i don't know if it's been mentioned recently, but there was a "trial" for LDN and MS run in Germany last year... it was 10 days (!) long, placebo-controlled and performed exclusively on patients with PPMS or SPMS and EDSS>5 (with the idea that if it can work on this very difficult-to-treat population, then it may be likewise for RRMS):

To very loosely summarize, it found quite contradictory results. Two findings of note were that only 1/3 of trialists responded to LDN, but of those that did, they dropped .5 on the EDSS in just ten days.

Last edited by Arron on Sun Jul 16, 2006 9:30 pm, edited 1 time in total.

Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.

Unfortunately, the design of that trial, from a scientific point of view, would pretty much be ignored in the world of MS medicine. You can't conduct a trial for 10 days and obtain any kind of meaningful data, especially for a disease like MS which has a huge variable in how it effects patients. In fact, I have never heard of ANY kind of clinical trial that lasted only 10 days!

I don't know what these docs were trying to accomplish but they certainly didn't do LDN any favors, one way or the other.

What really is needed is a properly designed clinical trial lasting at least one year. That would at least be a start on taking a serious look at LDN's effect on MS.

Since last Friday, October 6, and the first dose, my right thumb is completely normal (no longer numb), my palms are the same (no longer numb), I can stand from a crouched position much easier than before, and my left leg (the ms'ed up one) can now lift two feet off the ground rather than the four inches of last Friday morning.

Who is online

This site does not offer, or claim to offer, medical, legal, or professional advice.
All treatment decisions should always be made with the full knowledge of your physicians.
This is MS does not create, endorse, or republish any content.
All postings are the responsibility of the poster. All logos and trademarks in this site are property of their respective owners. All users must respect our rules for intellectual property rights.